Sep 21, 2005
Guidant Enrolls 300 Patients in Drug Eluting Stent Pivotal Trials and Completes Manufacturing Audit

Successful Inspection Brings Company One Step Closer to European Approval; Drug Eluting Stent Milestone Results in Payment to Novartis in Third Quarter

Indianapolis, Ind. - Guidant Corporation (NYSE: GDT) today announced that the company has enrolled more than 300 patients in its SPIRIT II and SPIRIT III clinical trials, meeting a milestone in the company''s exclusive license agreement with Novartis Pharma AG.

The company also announced that it has successfully concluded an inspection of its drug eluting stent manufacturing and quality systems at its Temecula site. This inspection was conducted by Guidant''s European Notified Body, which is also reviewing the company''s submission for approval to market the XIENCE(tm) V Everolimus Eluting Coronary Stent System in Europe. The Notified Body found no nonconformities and will recommend certification for Guidant.

"We are pleased with our recent progress with the XIENCE V Everolimus Eluting Coronary Stent System," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "Enrollment in SPIRIT II and SPIRIT III is progressing well, and successful completion of the audit brings us one step closer to approval to market the XIENCE V Coronary Stent System in Europe."

SPIRIT II and SPIRIT III are large-scale pivotal clinical trials evaluating the safety and efficacy of Guidant''s drug eluting stent system for the treatment of coronary artery disease. These prospective, randomized, single-blind trials compare XIENCE V, an everolimus eluting coronary stent system utilizing Guidant''s cobalt chromium MULTI-LINK VISION® Coronary Stent System platform, versus the TAXUS® Express 2(tm) Paclitaxel Eluting Coronary Stent System.

Novartis supplies everolimus to Guidant for use in drug eluting stents and provides access to data supporting Guidant filings with regulatory agencies. Under the terms of the agreement with Novartis, the milestone achievement will trigger a $60 million IPR&D charge in the third quarter of 2005, of which $40 million will be paid to Novartis in the third quarter. An additional $20 million will be paid by December 31, 2006.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 12,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.